What is required for a device to receive permission for clinical investigations?

For a device to receive permission for clinical investigations, an Investigational Device Exemption (IDE) is required. This regulatory approval allows the sponsor to use an investigational device in a clinical study to collect safety and effectiveness data. The IDE process is pivotal in ensuring that the studies are conducted ethically and that participants' rights are protected.

Obtaining an IDE also involves a review of the study protocol by the FDA, which evaluates aspects such as the potential risks to participants, the intended use of the device, and the study's design. Without an IDE, the device cannot be legally used in clinical trials, which are essential for gathering the information needed to support a future marketing application.

In contrast, while approval from investors and a detailed marketing plan may be important for a company's business strategy, they do not fulfill regulatory requirements for conducting clinical investigations. Similarly, a marketing authorization is not applicable in this context, because such authorization pertains to the approval for the commercial sale of a device after clinical data has been generated and analyzed, rather than the permission needed to conduct the investigations themselves.